Featured Research

from universities, journals, and other organizations

Recommendation for use of heart failure treatment formulated

Date:
March 19, 2010
Source:
University of Rochester Medical Center
Summary:
The FDA's Circulatory System Devices Panel recommended that the cardiac resynchronization therapy defibrillator (CRT--D), developed by Boston Scientific, be approved for use in patients with mild heart failure in the United States. If the device is approved by the FDA, nearly 4 million more Americans could be candidates for treatment with the CRT-D.

Cardiac resynchronization therapy defibrillator.
Credit: Image courtesy of University of Rochester Medical Center

A new therapy that reduces the risk of mortality and heart failure in patients with mild cardiac disease received a thumb's up this week from an advisory panel to the U.S. Food and Drug Administration. The panel recommended that the cardiac resynchronization therapy defibrillator (CRT-D), tested extensively nationwide under the leadership of cardiologist Arthur Moss, M.D., professor of Medicine at the University of Rochester Medical Center, be approved for use in patients with mild heart failure in the United States.

The device under review was developed by Boston Scientific and is already approved to treat patients with severe heart failure. With device approval by the FDA, nearly 4 million more Americans could be candidates for treatment with the CRT-D. The recommendations by its panels are often, but not always, followed by the FDA.

In the major study which tested the device -- the MADIT-CRT trial -- patients who had a cardiac resynchronization device combined with a defibrillator (CRT-D) implanted had a 34 percent reduction in their risk of death or heart failure compared to patients receiving only an implantable cardioverter defibrillator (ICD). Heart failure alone was reduced by 41 percent in all patients, with a remarkable 63 percent reduction of heart failure in women. The study results were published last year in the New England Journal of Medicine.

This week, Moss presented clinical data from the MADIT-CRT study at a meeting of the FDA's Circulatory System Devices panel showing that the combination of an implanted cardiac defibrillator, which detects irregular and potentially fatal heart rhythms and shocks the heart back into a normal rhythm, with cardiac resynchronization therapy, which improves the mechanical pumping action of the heart, provides preventive benefit to patients with more mild cardiac disease.

"The panel's recommended approval of this therapy is great news for a large population of patients in which it could effectively prevent heart failure progression," said Moss. "The ultimate goal of this new therapy is to not only help patients live longer, but to help them live better."

The new device combines two functions found in current devices: an ICD, which is designed to prevent sudden cardiac death, and cardiac resynchronization therapy, which works to reduce heart failure and associated symptoms.

About 70 percent of the approximately 5.5 million Americans with some form of heart failure, or 3.9 million people, have milder forms of heart failure known as "Class I" or "Class II," the forms considered by the FDA in its decision this week.

The MADIT-CRT study followed 1,820 patients from 110 medical centers in the United States, Canada and Europe for four-and-one-half years. The trial was sponsored by Boston Scientific through a research grant to the University of Rochester. The study is the world's largest randomized trial involving Class I and Class II heart failure patients.

Prior to MADIT-CRT, Moss and his colleagues at the University of Rochester directed MADIT-I and MADIT-II, which evaluated the safety and efficacy of ICDs in high-risk heart failure patients. These trials set the stage for MADIT-CRT and the evaluation of defibrillators with resynchronization therapy in lower-risk patients.


Story Source:

The above story is based on materials provided by University of Rochester Medical Center. Note: Materials may be edited for content and length.


Cite This Page:

University of Rochester Medical Center. "Recommendation for use of heart failure treatment formulated." ScienceDaily. ScienceDaily, 19 March 2010. <www.sciencedaily.com/releases/2010/03/100319142702.htm>.
University of Rochester Medical Center. (2010, March 19). Recommendation for use of heart failure treatment formulated. ScienceDaily. Retrieved July 31, 2014 from www.sciencedaily.com/releases/2010/03/100319142702.htm
University of Rochester Medical Center. "Recommendation for use of heart failure treatment formulated." ScienceDaily. www.sciencedaily.com/releases/2010/03/100319142702.htm (accessed July 31, 2014).

Share This




More Health & Medicine News

Thursday, July 31, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Health Insurers' Profits Slide

Health Insurers' Profits Slide

Reuters - Business Video Online (July 30, 2014) Obamacare-related costs were said to be behind the profit plunge at Wellpoint and Humana, but Wellpoint sees the new exchanges boosting its earnings for the full year. Fred Katayama reports. Video provided by Reuters
Powered by NewsLook.com
Concern Grows Over Worsening Ebola Crisis

Concern Grows Over Worsening Ebola Crisis

AFP (July 30, 2014) Pan-African airline ASKY has suspended all flights to and from the capitals of Liberia and Sierra Leone amid the worsening Ebola health crisis, which has so far caused 672 deaths in Guinea, Liberia and Sierra Leone. Duration: 00:43 Video provided by AFP
Powered by NewsLook.com
At Least 20 Chikungunya Cases in New Jersey

At Least 20 Chikungunya Cases in New Jersey

AP (July 30, 2014) At least 20 New Jersey residents have tested positive for chikungunya, a mosquito-borne virus that has spread through the Caribbean. (July 30) Video provided by AP
Powered by NewsLook.com
Xtreme Eating: Your Daily Caloric Intake All On One Plate

Xtreme Eating: Your Daily Caloric Intake All On One Plate

Newsy (July 30, 2014) The Center for Science in the Public Interest released its 2014 list of single meals with whopping calorie counts. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

    Environment News

    Technology News



      Save/Print:
      Share:

      Free Subscriptions


      Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

      Get Social & Mobile


      Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

      Have Feedback?


      Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
      Mobile: iPhone Android Web
      Follow: Facebook Twitter Google+
      Subscribe: RSS Feeds Email Newsletters
      Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins